OCUL: AXPAXLI Shows Unmatched Durability in Wet AMD Phase 3 Data

Ocular Therapeutix announced additional positive Week 52 data from the SOL-1 Phase 3 trial of AXPAXLI for wet AMD, presented at the VBS Meeting. The post-hoc analyses reinforced superior durability and sustained disease control, with a median time of 39 weeks to a ">="30 uM CSFT increase and 46 weeks to a ">="75 uM CSFT increase from Week 8. The company remains on track to submit its NDA based on SOL-1 alone, pending formal discussions with the U.S. FDA, aligning with recent FDA commentary on single pivotal trial approvals.